[unreadable] The purpose of the proposed Phase I research is to demonstrate feasibility of a new minimally invasive blood pump to provide mechanical circulatory assistance to the failing heart. Over 4.8 million Americans suffer from congestive heart failure (CHF), with 550,000 new cases appearing annually. Generally progressive, CHF is characterized by the inability of the heart to pump adequate blood to meet physiologic demands. Existing devices for mechanical circulatory support require open chest surgery, cardiopulmonary bypass and cannulation of the heart and major vessels for device implantation, and are associated with high morbidity and mortality. Consequently, their clinical use has been very limited and the event of an implantation is extraordinary rather than routine. Unique to the proposed device is the ability to be implanted by means of a minimally invasive approach, i.e., using techniques currently available to interventional cardiologists. A steerable catheter is introduced through the right brachiocephalic vein and into the right atrium via the superior vena cava. A needle positioned distally on this catheter creates a transseptal hole through which a dilator or dilatation catheter can be used to enlarge the opening. Use of a guide catheter or wire permits the pump to be advanced through this opening into position in the left atrium. The outflow cannula provides a transvalvular (mitral and aortic) conduit for antegrade flow through the left ventricle to the ascending aorta. A novel dual-impeller design will allow for lower speed operation, which is expected to reduce hemolysis due to shear gradients. The development team is experienced in the design of innovative blood pumps, particularly those amenable to minimally invasive techniques (i.e., the Hemopump). Phase I goals: 1) design and analyze prototype using finite element analysis of hydraulics and electomechanical coupling, 2) build working models and test fixtures, 3) conduct bench evaluation of pump performance, efficiency and thermal management, and 4) test for hemolysis using standard protocols. The success of this project will lead to a breakthrough technology that will provide a significant new treatment option in the management of CHF, likely reduce the morbidity and mortality associated with current device implantation, and reduce the cost of mechanical cardiac support. [unreadable] [unreadable]